Neoadjuvant Dalpiciclib Plus Aromatase Inhibitors in Lumi... | NCT05640778

Studies
Neoadjuvant Dalpiciclib Plus Aromatase Inhibitors in Luminal B/HER2-negative Breast Cancer (DANCER)

NCT05640778

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Status

Unknown status

Last Update Posted

Jan 31, 2024Actual

Enrollment

30Estimated

Phase

Phase 2

Conditions

Luminal B/HER2-negative Breast Cancer

Interventions

Dalpiciclib combined with aromatase inhibitors

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 1, 2022Actual

Primary Completion Date

Oct 31, 2024Estimated

Completion Date

Oct 31, 2025Estimated

First Submitted Date

Nov 30, 2022

First Submission Date that Met QC Criteria

Nov 30, 2022

First Posted Date

Dec 7, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 30, 2024

Last Update Posted Date

Jan 31, 2024Actual

Name	Class
GeneCast Biotechnology Co., Ltd.	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Evaluate the efficacy and safety of Dalpiciclib combined with aromatase inhibitors as a neoadjuvant therapy in Luminal B/HER2-negative breast cancer.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
neoadjuvant endocrine therapy	Experimental	CDK4/6 inhibitor combined with aromatase inhibitor	Drug: Dalpiciclib combined with aromatase inhibitors

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Dalpiciclib combined with aromatase inhibitors	Drug	Dalpiciclib combined with letrozole or anastrozole	neoadjuvant endocrine therapy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Complete cell cycle arrest（CCCA, defined as ki67≤2.7%）rate at 2 weeks of treatment	Assess ki67 level through biopsy samples of patients	3 years

Secondary Outcomes

Measure	Description	Time Frame
Objective response rate (ORR)	the proportion of people with clinical complete response(CR) or partial response(PR), per RECIST v1.1	3 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patient is ≥ 18 years-old at the time of consent to participate this trial
Famale stage I-III breast cancer patients
HR-positive（ER≥10%）, HER2-negtive invasive breast cancer, either Ki67≥20% and/or PgR<20%
No prior anti-cancer treatment
ECOG 0-1

Exclusion Criteria:

Known to have other aggressive malignant tumor in the past 5 years.
Bilateral breast cancer; Inflammatory breast cancer; Occult breast cancer; Distant metastasis confirmed by pathology.
There are other concomitant diseases that seriously threaten the patient's safety or affect the patient's completion of the study, such as serious infection, liver disease, cardiovascular disease, kidney disease, respiratory disease or uncontrolled diabetes or dyslipidemia.
Female patients during pregnancy or lactation.
The investigator determines that subjects are not appropriate to participate in the study due to other factors.

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Yunxiang Zhou	Contact	+8615868131018		yxzhou@zju.edu.cn

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
2nd Affiliated Hospital, School of Medicine, Zhejiang University	Recruiting	Hangzhou			China

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D047072	Aromatase Inhibitors

Ancestor Terms

ID	Term
D065088	Steroid Synthesis Inhibitors
D004791	Enzyme Inhibitors
D045504	Molecular Mechanisms of Pharmacological Action
D020228	Pharmacologic Actions

Browse Leaves

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Browse Branches

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